Investigators Manual

Part 1 - Overview

Ethical Codes
Conflicts of Interest
Regulatory Structure
Education:  Research Integrity 

Part II - IRB Structure and Process
The Institutional Review Board
Study Review Criteria

Part III - Informed Consent
Informed Consent Requirements
Documentation of Informed Consent (45 CFR § 46.117)
Waiver from the Entire Consent Process
Waiver of Consent for Studies of Emergency Situations

Part IV - NGHS IRB Procedural Guides

Three Basic Definitions
IRB Review
Possible IRB Decisions
Post Approval Activities


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